Restoril pill. Restoril (Temazepam): Uses, Side Effects, Interactions, and Dosage Guide
What is Restoril and how does it work. What are the common side effects of Restoril. How should Restoril be taken for optimal results. What precautions should be considered when using Restoril. How does Restoril compare to other sleep medications.
Understanding Restoril: A Comprehensive Overview
Restoril, also known by its generic name temazepam, is a prescription medication primarily used for the short-term treatment of insomnia. It belongs to a class of drugs called benzodiazepines, which work by enhancing the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that promotes relaxation and sleep in the brain.
Restoril is typically prescribed for individuals who have difficulty falling asleep or staying asleep throughout the night. It is generally recommended for short-term use, usually 7 to 10 days, as prolonged use can lead to dependence and tolerance.
Key Features of Restoril
- Active ingredient: Temazepam
- Drug class: Benzodiazepine
- Available forms: Oral capsules
- Common dosages: 7.5 mg, 15 mg, 22.5 mg, and 30 mg
- Onset of action: 30 minutes to 1 hour
- Duration of effect: 6 to 8 hours
Indications and Uses of Restoril
Restoril is primarily indicated for the treatment of insomnia. It can help patients who struggle with:
- Difficulty falling asleep
- Frequent nighttime awakenings
- Early morning awakenings
- Non-restorative sleep
While Restoril is effective for short-term use, it is not recommended for long-term treatment of chronic insomnia. For persistent sleep issues, healthcare providers may explore alternative treatments or underlying causes of sleep disturbances.
Off-label Uses
In some cases, Restoril may be prescribed off-label for other conditions, such as:
- Anxiety disorders
- Alcohol withdrawal symptoms
- Seizure disorders
It’s important to note that off-label use should only be under the guidance of a healthcare professional who has carefully weighed the potential benefits and risks.
Dosage and Administration Guidelines
The appropriate dosage of Restoril can vary depending on several factors, including age, health status, and the severity of insomnia. It’s crucial to follow the prescribing physician’s instructions carefully.
Typical Dosage Recommendations
- Adults: 7.5 mg to 30 mg taken once daily at bedtime
- Elderly or debilitated patients: 7.5 mg initially, which may be increased if necessary
- Patients with hepatic impairment: Lower doses may be recommended
Restoril should be taken immediately before bedtime and only when a full night’s sleep (7-8 hours) is possible. Taking the medication with or immediately after a high-fat meal may delay its effects.
Important Dosing Considerations
- Do not exceed the prescribed dose or take Restoril for longer than recommended.
- Avoid abrupt discontinuation, as this may lead to withdrawal symptoms.
- If a dose is missed, skip it and resume the regular dosing schedule the next night.
- Never take a double dose to make up for a missed one.
Common Side Effects and Adverse Reactions
While Restoril can be effective in treating insomnia, it may cause various side effects. It’s essential to be aware of these potential adverse reactions and report any concerning symptoms to a healthcare provider.
Frequently Reported Side Effects
- Drowsiness or daytime sedation
- Dizziness
- Lightheadedness
- Coordination problems
- Headache
- Nausea
- Dry mouth
- Confusion
- Memory problems
Most side effects are mild and tend to diminish as the body adjusts to the medication. However, if side effects persist or worsen, it’s important to consult a healthcare professional.
Serious Adverse Reactions
While rare, some individuals may experience more severe side effects that require immediate medical attention:
- Severe allergic reactions (anaphylaxis)
- Respiratory depression
- Suicidal thoughts or behaviors
- Unusual changes in mood or behavior
- Hallucinations
- Severe confusion or disorientation
If any of these serious side effects occur, seek medical help immediately.
Drug Interactions and Precautions
Restoril can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial to inform healthcare providers about all medications, supplements, and herbal products being used.
Common Drug Interactions
- Other central nervous system depressants (e.g., opioids, alcohol)
- Certain antidepressants (e.g., SSRIs, SNRIs)
- Antihistamines
- Antipsychotics
- Anticonvulsants
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
These interactions may increase sedation, impair cognitive function, or affect breathing. Always consult a healthcare provider or pharmacist before starting or stopping any medication while taking Restoril.
Special Precautions
Certain populations may be at higher risk for adverse effects and should use Restoril with caution:
- Elderly patients
- Individuals with a history of substance abuse
- Patients with respiratory disorders
- Those with liver or kidney impairment
- Pregnant or breastfeeding women
Healthcare providers will carefully consider the risks and benefits of prescribing Restoril in these situations.
Comparing Restoril to Other Sleep Medications
While Restoril is effective for many individuals, it’s not the only option for treating insomnia. Understanding how it compares to other sleep medications can help patients and healthcare providers make informed decisions.
Restoril vs. Ambien (Zolpidem)
- Both are used for short-term insomnia treatment
- Ambien is a non-benzodiazepine hypnotic, while Restoril is a benzodiazepine
- Ambien may have a faster onset of action
- Restoril may be more effective for sleep maintenance
Restoril vs. Lunesta (Eszopiclone)
- Lunesta is also a non-benzodiazepine hypnotic
- Lunesta may be prescribed for longer periods than Restoril
- Both can be effective for sleep onset and maintenance
- Lunesta may have a lower risk of next-day impairment
The choice between these medications depends on individual patient factors, including the specific nature of their sleep problems, medical history, and potential drug interactions.
Potential for Dependence and Withdrawal
As a benzodiazepine, Restoril carries a risk of physical and psychological dependence, especially with prolonged use or higher doses. Understanding this potential is crucial for patients and healthcare providers.
Signs of Dependence
- Needing higher doses to achieve the same effect (tolerance)
- Experiencing withdrawal symptoms when stopping the medication
- Continued use despite negative consequences
- Difficulty controlling use or cutting down
Withdrawal Symptoms
Abruptly stopping Restoril after regular use can lead to withdrawal symptoms, which may include:
- Rebound insomnia
- Anxiety and irritability
- Tremors
- Sweating
- Nausea and vomiting
- In severe cases, seizures or hallucinations
To minimize the risk of withdrawal, healthcare providers typically recommend a gradual tapering of the dose when discontinuing Restoril, especially after long-term use.
Non-Pharmacological Approaches to Insomnia Management
While Restoril can be effective for short-term insomnia treatment, it’s often recommended in conjunction with non-pharmacological approaches. These strategies can help improve sleep quality and may reduce the need for medication over time.
Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I is considered the gold standard for non-pharmacological insomnia treatment. It typically involves:
- Sleep hygiene education
- Stimulus control therapy
- Sleep restriction
- Relaxation techniques
- Cognitive restructuring
Lifestyle Modifications
Simple changes in daily habits can significantly improve sleep quality:
- Maintaining a consistent sleep schedule
- Creating a relaxing bedtime routine
- Optimizing the sleep environment (temperature, noise, light)
- Limiting caffeine and alcohol intake, especially in the evening
- Regular exercise (but not too close to bedtime)
- Managing stress through techniques like meditation or yoga
Combining these non-pharmacological approaches with Restoril, when prescribed, can lead to more comprehensive and sustainable improvements in sleep quality.
Monitoring and Follow-up for Restoril Use
Regular monitoring is essential when using Restoril to ensure its effectiveness and safety. Healthcare providers typically schedule follow-up appointments to assess the medication’s impact and address any concerns.
Key Aspects of Monitoring
- Evaluating sleep quality and daytime functioning
- Assessing for side effects or adverse reactions
- Checking for signs of dependence or tolerance
- Reviewing the need for continued treatment
- Considering dose adjustments if necessary
Patients should keep a sleep diary and note any changes in sleep patterns or overall well-being to discuss with their healthcare provider during these follow-ups.
Long-term Considerations
For patients who require longer-term treatment for insomnia, healthcare providers may:
- Explore alternative medications or treatment approaches
- Implement intermittent dosing schedules to minimize dependence risk
- Emphasize non-pharmacological strategies for sleep improvement
- Consider referral to a sleep specialist for comprehensive evaluation
Open communication between patients and healthcare providers is crucial for optimizing the use of Restoril and managing insomnia effectively over time.
Restoril Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
See also Warning section.
Dizziness or difficulty with coordination may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.
This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake (“sleep-driving”). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking temazepam.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Temazepam Uses,Images & Side effects
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Restoril 15 mg
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Restoril 30 mg
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Temazepam 30 mg-PUR
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Temazepam 7. 5 mg-GG
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Differences, similarities, and which is better for you
Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ
Restoril and Ambien are two prescription medications used in the treatment of insomnia. Insomnia is a sleeping disorder characterized by having trouble falling asleep, staying asleep, or getting good quality sleep. A lack of sleep can leave patients feeling sleepy and unrested, making daily activities difficult.
Insomnia can be categorized two ways: short-term insomnia can last a few days or weeks and is typically brought on by a change in schedule or stressors, and chronic insomnia occurs three or more nights per week over three or more months and cannot be explained by a life change, medication, or other known cause. Healthcare providers may suggest environmental changes and cognitive behavioral therapy prior to beginning sleep aid medications.
Restoril and Ambien both treat forms of insomnia, though they are not the same. We will discuss their differences here.
What are the main differences between Restoril and Ambien?
Restoril (temazepam) is a prescription drug that is used in the treatment of short-term insomnia. It is a benzodiazepine used as a sedative-hypnotic. Benzodiazepines are central nervous system (CNS) depressants. CNS depressants result in many effects including sedation, hypnosis, anticonvulsant, and muscle relaxation. These effects are brought on by non-specific binding to gamma-aminobutyric acid-A (GABA-A) receptors that have multiple omega subunits, each responsible for various effects. Restoril is available as an oral capsule in strengths of 7.5 mg, 15 mg, 22.5 mg, and 30 mg. Restoril is considered a controlled substance by the Drug Enforcement Agency (DEA) because it can be habit-forming and have the potential for abuse.
Ambien (zolpidem) is a prescription drug that is used in the treatment of short-term insomnia, particularly in patients for whom initiating sleep and maintaining sleep is the obstacle. Ambien is a positive modulator at the GABA-A receptor as well but is different from benzodiazepines in that it has a higher affinity specifically for the omega-1 subunit of the GABA-A receptor. Ambien is a non-benzodiazepine sedative-hypnotic. This is thought to explain why Ambien has a somnolent effect, but no effects related to muscle relaxation, anxiety, or seizure activity. Ambien is available as an oral immediate-release tablet in 5 mg and 10 mg, as well as extended-release tablets in 6.25 mg and 12.5 mg. Ambien is also characterized as a controlled substance by the DEA.
Main differences between Restoril and Ambien | ||
---|---|---|
Drug class | Benzodiazepine | Non-benzodiazepine sedative |
Brand/generic status | Brand and generic available | Brand and generic available |
What is the generic name? | Temazepam | Zolpidem |
What form(s) does the drug come in? | Oral capsule | Oral immediate- and extended-release tablets |
What is the standard dosage? | 30 mg at bedtime | 10 mg at bedtime |
How long is the typical treatment? | A few days to weeks | Months |
Who typically uses the medication? | Adults | Adults |
Conditions treated by Restoril and Ambien
Restoril is indicated in the treatment of short-term insomnia. Short-term insomnia typically lasts a few days or weeks and is generally related to a particular stressor or change in sleep schedule.
Ambien, in its immediate-release form, is used in short-term insomnia characterized by difficulty initiating sleep, or falling asleep. Ambien CR, the extended-release formulation, is used to treat insomnia characterized by trouble initiating sleep and/or sleep maintenance or staying asleep.
Short-term insomnia | Yes | Yes |
Chronic insomnia (with trouble initiating or staying asleep) | No | Yes |
Is Restoril or Ambien more effective?
Restoril and Ambien were compared in a placebo-controlled clinical trial. This trial included more than 600 patients with transient, or short-term, insomnia. While both drugs were shown to improve the efficiency of sleep as compared to placebo, Ambien was superior in reducing the number of awakenings after sleep onset. In other words, patients were less likely to wake up through the night with Ambien as compared to Restoril. Given this information, and taking into consideration that Ambien avoids unwanted effects on muscle relaxation and seizure activity, your prescriber may choose Ambien for your short-term insomnia.
Only your physician can determine which medication is best for you and your particular sleep disorder. This is not intended to be medical advice.
Coverage and cost comparison of Restoril vs. Ambien
Restoril is typically covered by commercial insurance plans, but generally not covered by Medicare drug plans. The out-of-pocket price for Restoril is around $60, but with a coupon from SingleCare, you can lower the generic price to approximately $10 at participating pharmacies.
Ambien is also typically covered by commercial insurance plans, but generally not covered by Medicare drug plans. The out-of-pocket price for brand-name Ambien can run up to $600-$700. SingleCare’s coupon for generic Ambien (zolpidem tartratean) can lower the price to $14 at many pharmacies.
Typically covered by insurance? | Yes | Yes |
Typically covered by Medicare Part D? | No, exceptions are plan dependent | No, exceptions are plan dependent |
Quantity | 30, 30 mg capsules | 30, 10mg immediate-release tablets |
Typical Medicare copay | n/a | n/a |
SingleCare cost | $10-$37 | $14-$29 |
Common side effects of Restoril vs. Ambien
Restoril and Ambien have a significant number of potential side effects. Headache, fatigue, and nervousness are possible with both drugs. Both drugs have the potential to leave patients with a hangover effect or drugged feeling, which can affect daily functioning. It is important to plan to get a minimum of eight hours of sleep after taking these medications in order to help avoid this effect.
Nightmares, vivid dreams, and abnormal dreams are possible with Restoril and Ambien. In some instances, there have been reports of binge eating, sexual activity, and other abnormal activities while patients are reportedly still asleep (sleepwalking). These potential adverse effects should be discussed with your doctor.
This is not intended to list all potential effects of these medications. Your doctor may discuss other possible adverse effects.
Side effect | Applicable? | Frequency | Applicable? | Frequency |
Drowsiness | Yes | 9.1% | Yes | 8% |
Headache | Yes | 8.5% | Yes | Not defined |
Fatigue | Yes | 4.8% | Yes | Not defined |
Nervousness | Yes | 4.6% | Yes | Not defined |
Lethargy | Yes | 4. 5% | Yes | 3% |
Dizziness | Yes | 4.5% | Yes | 5% |
Abnormal Dreams | No | n/a | Yes | 1% |
Nausea | Yes | 3.1% | Yes | Not defined |
Hangover | Yes | 2.5% | Yes | 3% |
Anxiety | Yes | 2.0% | Yes | Not defined |
Depression | Yes | 1.7% | No | n/a |
Dry Mouth | Yes | 1.7% | Yes | 3% |
Diarrhea | Yes | 1.7% | Yes | 3% |
Abdominal Pain | Yes | 1.5% | Yes | 2% |
Constipation | No | n/a | Yes | 2% |
Euphoria | Yes | 1.5% | Yes | Not defined |
Weakness | Yes | 1.4% | No | n/a |
Confusion | Yes | 1. 3% | Yes | Not defined |
Blurred vision | Yes | 1.3% | No | n/a |
Nightmares | Yes | 1.2% | No | n/a |
Vertigo | Yes | 1.2% | Yes | Not defined |
Allergy | No | n/a | Yes | 4% |
Source: Restoril (DailyMed) Ambien (DailyMed)
Drug interactions of Restoril vs. Ambien
Restoril and Ambien both have CNS depressant effects, and their concomitant use with other CNS depressants may lead to an additive effect, which could be dangerous. Most notably, use with opiate pain relievers can lead to severe respiratory depression and possibly even death. Common opiate pain relievers include codeine, hydrocodone, and oxycodone.
Caffeine, especially if consumed in the time shortly before taking Restoril or Ambien, may counteract the desired effects of Restoril and Ambien. Caffeine is pharmacologically opposite of Restoril and Ambien in that it stimulates the central nervous system.
Commonly used antihistamines, such as Benadryl (diphenhydramine), may also cause significant sleepiness and should not be given with Restoril and Ambien as the additive effect could be dangerous.
This is not intended to be an all-inclusive list of potential drug interactions. Please consult your pharmacist or healthcare professional for a complete list.
Codeine Hydrocodone Morphine Hydromorphone Oxycodone | Opioid pain relievers | Yes | Yes |
Caffeine | Simulant | Yes | Yes |
Aripiprazole Olanzapine Quetiapine | Atypical antipsychotics | Yes | Yes |
Brompheniramine Chlorpheniramine Diphenhydramine Hydroxyzine Cetirizine | Antihistamines | Yes | Yes |
Carisoprodol Metaxalone Cyclobenzaprine | Muscle relaxants | Yes | Yes |
Clonidine | Alpha agonist | Yes | No |
Tramadol | Mu-opioid pain reliever | Yes | Yes |
Trazodone | Antidepressant | Yes | Yes |
Amitriptyline Doxepin Nortriptyline Imipramine | Tricyclic antidepressants | Yes | Yes |
Citalopram Escitalopram Fluoxetine Sertraline | Selective serotonin reuptake inhibitors (SSRIs) | No | Yes |
Warnings of Restoril and Ambien
The use of Restoril and Ambien with other CNS depressants, such as opioid pain relievers, may lead to profound sedation, respiratory depression, coma, and even death. The use of Restoril and Ambien together should be avoided for the same reason.
It is important to note that if insomnia does not improve within seven to 10 days of taking medication, patients should be evaluated for underlying psychiatric disorders that may be contributing to sleep problems if untreated.
Restoril and Ambien should be avoided if a patient has consumed alcohol within a few hours of bed, or does so on a regular basis. The combination leads to psychomotor impairment that can last into the next day, and may impair driving and reflex times.
Before taking Ambien or Restoril, please alert your doctor to any medical conditions or other medications you are taking, including over-the-counter medications and other sleep medications.
Do not suddenly stop taking Restoril or Ambien without consulting your healthcare provider. You might experience withdrawal symptoms such as agitation, anxiety, and depression.
Frequently asked questions about Restoril vs.
Ambien
What is Restoril?
Restoril is a prescription medication used in the treatment of short-term insomnia. It is classified as a benzodiazepine and is also considered a controlled substance by the DEA due to its potential for abuse. It is available as an oral capsule in strengths of 7.5 mg, 15 mg, 22.5 mg, and 30 mg.
What is Ambien?
Ambien is a prescription medication used to treat insomnia. It is a non-benzodiazepine sedative drug but is still considered a controlled substance by the DEA because of its potential for abuse. It is available in immediate-release tablet form in 5 mg and 10 mg strengths. It is also available in extended-release tablet form (Ambien CR) in strengths of 6.25 mg and 12.5 mg.
Are Restoril and Ambien the same?
While both Restoril and Ambien treat insomnia, they are not the same. Restoril is a benzodiazepine that also has effects on muscle relaxation, convulsions, and anxiety. Ambien is not a benzodiazepine and has a more specific receptor target and avoids these effects while targeting insomnia.
Is Ambien or Restoril better?
While both Restoril and Ambien are capable of improving the efficiency of sleep, Ambien has been shown to be significantly better at reducing the number of awakenings after falling asleep. Given this, and the more specific activities toward sleep, Ambien may be preferred over Restoril.
Can I use Restoril or Ambien while pregnant?
Restoril is categorized by the Food and Drug Administration (FDA) as pregnancy category X. It is contraindicated in pregnancy and should not be used. Ambien is pregnancy category C indicating that there have been no well-controlled studies to prove safety and efficacy. Ambien should only be used when benefits clearly outweigh the risks.
Can I use Restoril or Ambien with alcohol?
Patients should avoid taking Restoril or Ambien if they have consumed alcohol in the hours leading up to sleep. Significant psychomotor impairment can result from concomitant use.
What sleeping pill works better than Ambien?
Lunesta (eszopiclone) offers some advantage over Ambien in that it is considered safe to be used long term, whereas Ambien is intended for relatively short-term use. Lunesta has been shown to be highly effective for sleep maintenance.
Does Restoril help with anxiety?
Restoril is a benzodiazepine and does possess anxiolytic effects, making it an effective anti-anxiety medication.
How fast does Restoril work?
Temazepam works within 15 to 30 minutes of taking it and should be taken 15 to 30 minutes prior to the desired time to be asleep.
Temazepam: MedlinePlus Drug Information
Temazepam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take temazepam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
Temazepam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with temazepam also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.
Temazepam may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you take it for several days to several weeks. Do not stop taking this medication or take fewer doses without talking to your doctor. Stopping temazepam suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your temazepam dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.
temazepam | Michigan Medicine
What is the most important information I should know about temazepam?
Temazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.
MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Do not use if you are pregnant.
What is temazepam?
Temazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat insomnia (trouble falling or staying asleep).
Temazepam may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking temazepam?
You should not use this medicine if you are allergic to temazepam or similar medicines (such as alprazolam, diazepam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Valium, Versed, Xanax, and others).
Do not use temazepam if you are pregnant. It could harm the unborn baby.
If you use temazepam while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Tell your doctor if you have ever had:
- lung disease or breathing problems;
- depression, mental illness, suicidal thoughts;
- alcoholism or drug addiction; or
- liver or kidney disease.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Temazepam is not approved for use by anyone younger than 18 years old.
How should I take temazepam?
Follow the directions on your prescription label and read all medication guides. Never use temazepam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.
Never share temazepam with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Take this medicine only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.
Call your doctor if your insomnia does not improve after taking temazepam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.
Do not stop using temazepam suddenly or you could have unpleasant withdrawal symptoms. Follow your doctor’s instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
What happens if I miss a dose?
Since temazepam is used when needed, you may not be on a dosing schedule. Take temazepam only when you have time for several hours of sleep. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of temazepam can be fatal, especially if taken with alcohol.
Overdose symptoms may include extreme drowsiness, confusion, or loss of consciousness.
What should I avoid while taking temazepam?
Do not drink alcohol. Dangerous side effects or death could occur.
You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.
What are the possible side effects of temazepam?
Temazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.
Temazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.
Call your doctor at once if you have:
- confusion, agitation, hallucinations;
- depressed mood; or
- thoughts of suicide or hurting yourself.
Some people using temazepam have engaged in activity such as driving, eating, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.
The sedative effects of temazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines.
Common side effects may include:
- day-time drowsiness or “hangover” feeling;
- headache;
- dizziness, tiredness;
- nausea; or
- feeling nervous.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect temazepam?
Taking temazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Other drugs may affect temazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about temazepam.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2021 Cerner Multum, Inc. Version: 11.01. Revision date: 12/8/2020.
How Long Does Restoril (Temazepam) Stay in Your System?
Restoril (temazepam) is a medication that slows the activity of your brain. It is prescribed as a short-term sleeping aid for people with insomnia. As it can be habit-forming, it is not usually prescribed for longer than 10 days.
Restoril is in a class of drugs called benzodiazepines, which are central nervous system depressants and Schedule IV controlled substances. When combined with other depressants or alcohol, or when taken in large dosages, Restoril can cause a loss of consciousness and respiratory failure.
To avoid negative drug interactions, it’s important to know how long the medication will stay in your system. Restoril can be detected in your body from one to 90 days, depending on factors like dosage, age, weight, and metabolism, as well as the type of detection test used.
How Long Does Restoril Stay in Your System?
Blood: Up to 24 hours
Urine: Up to one week
Saliva: Up to 24 hours
Hair: Up to 90 days
How Long Does It Take to Feel the Effects?
Restoril is classified as a short- to intermediate-acting benzodiazepine. It begins to work in 10 to 20 minutes after you take a dose. The levels of the medication will peak about one and a half hours later.
It’s recommended that you only take Restoril if you are able to stay in bed for seven to eight hours before you have to get up again (which is about how long you will be affected by the medication).
Restoril Side Effects
Common side effects of Restoril include:
- Anxiety
- Depression
- Dizziness
- Drowsiness
- Dry mouth
- Feeling groggy the next day
- Headache
- Lethargy
- Nausea
- Nervousness
While it is uncommon, you might experience sleepwalking while you are taking Restoril. Episodes of sleepwalking can include engaging in activities such as driving, cooking, talking on the phone, and having sex with no memory of having done these things.
Tell your healthcare provider about any side effects you experience that get worse or do not go away.
How Long Does Restoril Last?
The half-life of a drug is the time it takes for half the drug to be eliminated from your system. It takes five to seven half-lives to clear out 98% of a drug dose. The amount of time a benzodiazepine remains in your system partly depends on what type it is: ultra-short, short, intermediate, or long-acting.
Ultra-short benzodiazepines have a half-life of fewer than five hours, while short- to intermediate-acting benzodiazepines like Restoril have a half-life from five to 24 hours. Long-acting benzodiazepines have a half-life exceeding 24 hours.
The average half-life of Restoril is around 9 hours.
Restoril is metabolized by your liver with a half-life in two phases—one short and one long. Most of the drug is excreted in your urine. In general, the typical detection windows for benzodiazepines are different for urine, blood, and saliva, and hair.
Urine
A typical therapeutic dose of Restoril will appear positive on a urine drug screen (such as those done for employment purposes) for an average of five days to a week. Heavier or longer use of the medication can create a positive urine test for weeks.
Blood
Restoril clears out of your bloodstream much faster than it does from your urine. It is usually only detectable in blood for up to 24 hours.
Saliva
Restoril can be detectable in your saliva for 24 hours or longer.
Hair
As with all drugs, Restoril can be detected in your hair. The range of detection for Restoril starts at about two to three weeks after you take the medication and can go up to three months after your last dose.
False Positive Testing
Certain medications may cause a false positive urine screen for Restoril. The antidepressant medication Zoloft (sertraline) and prescription non-steroidal anti-inflammatory drug Daypro (oxaprozin) reportedly can cause a false-positive urine test for benzodiazepines like Restoril.
Certain medications, including some antidepressants, can cause a false-positive result for Restoril on a drug screen.
If you are taking Restoril and need to take a drug screening for work, tell the testing laboratory before giving a sample. This will help them interpret your results. You might also want to inform your employer (or prospective employer) that you’re taking Restoril ahead of time.
Factors That Affect Detection Time
How long Restoril is detectable in your body depends on many variables, including your metabolism, weight, amount of body fat, and hydration status. The amount of Restoril that you take and how long you have been taking it, as well as the type of test that is used, will also affect your results.
Age
Your age can play a factor in the half-life of Restoril. The average half-life of the drug is higher for healthy older adults than it is for healthy young adults.
Weight
Being overweight makes it more difficult for your body to eliminate Restoril, which can increase the half-life of the drug.
Metabolism
People who have a higher metabolism (which can be influenced by hydration, age, activity level, and other health conditions) tend to be able to excrete Restoril faster than people with a slower metabolic rate.
Alcohol Use
Combining alcohol and Restoril can cause a fatal overdose. Alcohol can increase Restoril’s sedative effects as well as make it harder for your body to break down the drug.
Symptoms of Overdose
Restoril can be habit-forming. It’s important to take the medication according to the schedule and dosage that your healthcare provider has prescribed. Misuse of Restoril can lead to symptoms of an overdose, such as:
- Confusion
- Dizziness
- Difficulty breathing
- Drowsiness
- Loss of consciousness
If you think someone has overdosed on Restoril, call poison control at 1-800-222-1222. If the person has a seizure, loses consciousness, or has difficulty breathing, call 911.
Allergic Reactions
It is also possible to develop a severe allergic reaction to Restoril. Symptoms of an allergic reaction can include:
- Difficulty breathing or swallowing
- Hives
- Hoarseness
- Rash
- Swelling of your face
If you are taking Restoril and have symptoms of an allergic reaction, go to your nearest emergency room or call 911.
Drug Interactions
You should avoid drinking alcohol, using street drugs, or taking opiates (such as codeine, hydrocodone, fentanyl, hydromorphone, meperidine, methadone, morphine, oxycodone, or tramadol) while you are taking Restoril.
Combing Restoril with these medications and substances increases your risk of developing life-threatening breathing problems, sedation, coma, or death.
Other drugs that can potentially cause negative interactions with Restoril include:
To avoid potentially serious drug interactions, it’s important that you tell your doctor about all the medications you are taking. This includes any over-the-counter (OTC) drugs, herbal supplements, vitamins, or alternative remedies.
Getting Help
If you need or want to stop taking Restoril, you need to taper off the drug gradually and under the guidance of your doctor. If you suddenly stop taking Restoril, you may experience symptoms of benzodiazepine withdrawal. Withdrawal symptoms can range from mild to severe and can include:
- Depressed mood
- Seizures
- Shakiness
- Stomach and muscle cramps
- Sweating
- Trouble sleeping
- Vomiting
Restoril is safe for most people who take it as prescribed. However, people who have a history of alcohol or substance use disorders might be at an increased risk for misuse or addiction when taking Restoril.
New users of sleeping pills like Ambien, Restoril, Desyrel, have more car crashes
Sedative sleeping pills such as Ambien can nearly double the risk for car accidents among new users compared with nonusers, new research suggests.
University of Washington researchers found an increased risk for crashes for people taking Restoril (temazepam), Desyrel (trazodone) or Ambien (zolpidem).
That risk continued for up to a year among regular users, according to the study.
“Risks associated with sleeping pills have been known for some time, though this study shows some compelling real-world consequences,” said Michael Grandner, an instructor in psychiatry at the University of Pennsylvania in Philadelphia, who had no involvement with the study.
Doctors, pharmacists and patients should discuss this potential risk when selecting a sleep medication, the researchers said.
Concerns about Ambien have increased in recent years. To cut down on hazards linked to daytime drowsiness, the U.S. Food and Drug Administration in 2013 required lower recommended doses of Ambien products, labeling changes and a recommendation to avoid driving the day after taking extended-release Ambien CR.
“This finding is shockingly not shocking. Sleeping pills are a huge problem,” said Dr. Christopher Winter, a spokesman for the American Academy of Sleep Medicine.
“This study screams that many doctors do not know how to treat sleep patients,” he said. “You have to develop a plan to deal with their sleep, not merely sedate them.”
The recommended first-line treatment for insomnia is not medication, but cognitive behavioral therapy, Grandner said. This type of talk therapy “uses a set of tools to change your schedule and essentially reprogram your brain for sleep,” he explained.
Cognitive behavioral therapy is effective and much safer than many prescription sleeping medications, Grandner said. “If you have severe insomnia, you may wish to seek out an insomnia specialist who is trained to fix these sorts of problems without sleeping medications,” he added.
For the new report, published online June 11 in the American Journal of Public Health, Ryan Hansen of the University of Washington in Seattle, and colleagues looked at prescription records and motor vehicle crash records of more than 400,000 Washington state drivers who had a drug benefit in the Group Health Cooperative insurance plan. Participants were followed until death, unenrollment or the study’s end.
Trazodone — an antidepressant used for insomnia — was the most commonly prescribed sedative, followed by temazepam (Restoril) and zolpidem (Ambien), the findings showed.
Of the three drugs, which are all considered sedative hypnotic medications, temazepam appeared to have the least risk for crashes, the study found.
Overall, the risk of crashing related to use of these sedatives was similar to the crash risk associated with driving drunk, the researchers said.
The trouble, Winter said, is that Americans are fixated on sleep and getting to sleep fast. They may not realize that many sleeping pills are addictive and can worsen the quality of your sleep, he added.
Sleeping pills have their uses, Winter acknowledged. They can help people who have suffered a tragic event or need to adjust to a new work schedule, but they should not become a regular habit, he said.
Someone who has a couple of nights of bad sleep shouldn’t panic, Winter said. It is worry about not sleeping that adds to sleep problems and can perpetuate insomnia, he explained.
“There is no harm to insomnia,” he added.
“Maybe my night will be terrible and maybe I’ll be sleepy tomorrow,” is how Winter looks at a restless night. “I can deal with that. By the next night my sleep will be fine.”
Rivotril :: Instruction :: Price :: Description of the drug
Rivotril
Rivotril tablets and solution are based on clonazepam.
Auxiliary components of the tablets are lactose, corn and potato starch, iron dioxide, talc, iron trioxide, magnesium stearate, MCC.
Additional components of the solution are absolute alcohol, benzyl alcohol, glacial acetic acid, propylene glycol, water for injection.Water for injection is attached to the preparation as a solvent.
Benzodiazepine anticonvulsant drug – Rivotril, has a therapeutic effect due to the main component clonazepine. The drug enhances the effect of gamma-aminobutyric acid, slowing down the transmission of nerve impulses, reduces the excitability of the cerebral subcortex and the rate of postsynaptic spinal reflexes. Presynaptic inhibition helps prevent the spread of epileptogenic activity without affecting excitation in the focus.
The anxiolytic effect of Rivotril is manifested in the reduction of emotional stress, anxiety, anxiety and fear by interacting with the amygdala complex. Influencing the nonspecific nuclei of the optic tubercle and the reticular formation, the drug reduces neurotic symptoms.
In addition to the anticonvulsant effect, Rivotril has a muscle relaxant, hypnotic and sedative effect.
Rivotril, as an agent of the first row, is indicated for use in epilepsy: atypical and typical absences, nodding convulsions, atonic seizures.
As an agent of the second row, the drug is indicated for the treatment of infantile spasms.
For tonic-clonic seizures, partial seizures, secondary generalized convulsive seizures, Rivotril is used as a third-line remedy.
In case of status epilepticus, intravenous administration of the medication is indicated.
The use of Rivotril is indicated for somnambulism, muscle hypertonia, psychomotor agitation, insomnia, alcohol withdrawal, panic attacks.
Rivotril tablets are intended for oral administration, solution – for intravenous administration. The effective dose is calculated individually. The daily dose is divided into 3-4 applications. Supportive therapy is started 14–21 days after the start of treatment. When administered intravenously, a single dose is 1 mg for adults and 500 mcg for children. For parenteral administration, Rivotril should be diluted with the supplied diluent.
Adults at the beginning of therapy are shown to use 1 mg / day., the maintenance dose is 4–8 mg / day.
For children from 1 to 5 years of age, treatment begins with the use of up to 250 mcg / day, over 5 years – 500 mcg / day. Supportive therapy consists in the use of 0.5-1 mg / day for children under one year old, 1-3 mg / day for 1-5 years, 3-6 mg / day for 5-12 years.
Elderly patients start treatment with 500 mcg / day.
Treatment with Rivotril often provokes the development of headache, lethargy, increased fatigue, drowsiness, dizziness, lethargy, numbness.
Hypotension, agranulocytosis, tachycardia, respiratory depression, leukopenia, anemia, thrombocytopenia, neutropenia, transient alopecia develop infrequently with the use of the drug.
Rarely, the use of Rivotril contributes to the development of ataxia, liver dysfunction, confusion, articulation disturbances, diplopia, paradoxical reactions, hyperergic reactions, dry mouth, nystagmus, nausea, stool disorders, decreased appetite, dysmenorrhea, changes in libido, renal dysfunction, allergic reactions, changes in pigmentation, anterograde amnesia, urinary incontinence.
For children, the characteristic side symptoms are increased salivation, bronchial hypersecretion, premature puberty.
With a sharp withdrawal of Rivotril, withdrawal syndrome develops.
Rivotril should not be used for myasthenia gravis, respiratory depression, acute alcohol intoxication, severe forms of COPD, severe depression, acute respiratory failure, coma, angle-closure glaucoma, poisoning with hypnotics and narcotic analgesics, shock.
The drug is contraindicated in case of allergy to the components of dosage forms.
Rivotril is prohibited to use for the treatment of premature and newborn babies.
The use of Rivotril during pregnancy is prohibited.
Do not breastfeed during antiepileptic treatment.
The depressing effect of Rivotril on the central nervous system is enhanced by the use of drugs with the same effect and ethanol.
The effect of muscle relaxants is enhanced by treatment with Rivotril.
Rivotril reduces the effects of sodium valproate and can cause seizures.
Rivotril affects the pharmacological action of desipramine.
The metabolism of Rivotril is accelerated by treatment with carbamazepine.
The use of caffeine reduces the effect of Rivotril.
The concentration of Rivotril decreases with the use of lamotrigine.
The likelihood of developing neurotoxicity and pathologies of the central nervous system increases with treatment with Rivotril with lithium carbonate and cimetidine.
The concentration of primidone and toremifene is reduced by the action of Rivotril.
The likelihood of developing headache increases with the treatment of Rivotril with phenelzine.
Exceeding the dose of Rivotril is manifested by depression of the central nervous system, drowsiness, confusion, depression of respiration and reflexes, coma.
Rivotril is available in the form of a solution and tablets.
Clonazepam 0.5 or 2 mg tablets are packaged in darkened glass vials. The package can contain 50 tablets of 0.5 mg, 30 or 100 tablets of 2 mg.
Solution for intravenous administration of 1 mg of clonazepam in 1 ml is poured into 1 ml ampoules. One package consists of 5 ampoules with medication and ampoules with solvent.
Up to +25 degrees Celsius, protected from moisture and light, out of the reach of children.
Clonazepam, Clonotril.
See also the list of analogues of the drug Rivotril.
Status epilepticus (G41)
N03AE01
F.Hoffmann-La Roche
Country of origin – Switzerland.
The manual was compiled by a team of authors and editors of the Piluli website. The list of authors of the reference book of medicines is presented on the page of the site editorial office: Site editorial board.
References to used sources of information.
Description of the drug “ Rivotril ” on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult with your doctor and familiarize yourself with the annotation approved by the manufacturer.
Information on the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the doses and methods of its use.
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Memorial Sloan Kettering Cancer Center
This document, provided by Lexicomp ® , contains all the information you need to know about the drug, including the indications, route of administration, side effects, and when you should contact your healthcare provider.
Trade names: USA
KlonoPIN
Trade names: Canada
APO-ClonazePAM; Clonapam; CO ClonazePAM [DSC]; DOM-ClonazePAM [DSC]; DOM-ClonazePAM-R [DSC]; MYLAN-ClonazePAM [DSC]; PMS-ClonazePAM; PMS-ClonazePAM-R; PRO-ClonazePAM; RIVA-ClonazePAM; Rivotril; SANDOZ ClonazePAM [DSC]; TEVA-ClonazePAM [DSC]
Warning
- This drug is a benzodiazepine. Concomitant use of benzodiazepines with opioids has resulted in very severe side effects.Side effects observed included slowing or difficult breathing and death. Opioids include drugs such as codeine, oxycodone, and morphine. Opioids are used to treat pain and some are used to treat coughs. Consult your doctor.
- If you are taking this drug with an opioid, get medical help right away if you feel very sleepy or dizzy, if you have slow, shallow, or difficult breathing, or if you pass out.Caregivers or others should seek immediate medical attention if the patient does not respond, does not respond or does not respond normally, or if he is asleep and does not wake up.
- There may be a risk of dependence, abuse or misuse when using benzodiazepines. Misuse or abuse of this medication can lead to overdose or death, especially when used in conjunction with certain other drugs, alcohol, or drugs.Addiction can occur even if you use this drug as directed by your doctor. Get immediate medical attention if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.
- You will be closely monitored to avoid misuse, abuse or dependence on this drug.
- Benzodiazepines may be addictive.Reducing the dose or stopping suddenly from this drug may cause withdrawal. This can be life threatening. The risk of addiction and withdrawal increases with long-term or high-dose use of this drug. Talk to your doctor before lowering the dose or stopping this drug. Follow your doctor’s instructions. Seek immediate medical attention if you experience problems controlling body movements, seizures, behavior or mood changes, such as depression or suicidal thoughts, thoughts of harming someone, hallucinations (vision or auditory perception), appear or become more severe non-existent things), loss of contact with reality, stupid movements or conversations, or any other side effects.
- Sometimes withdrawal symptoms can last from several weeks to more than 12 months. Tell your doctor if you have anxiety; problems with memory, learning, or concentration; sleep problems; burning, numbness, or tingling; weakness; tremor; muscle twitching; ringing in the ears or any other side effects.
What is this drug used for?
- Used to treat seizures.
- Used to treat panic attacks.
- This drug may be used for other indications. Consult your doctor.
What do I need to tell my doctor BEFORE taking this drug?
- If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.
- In one of the following: glaucoma or liver disease.
- If you are breastfeeding.Do not breast-feed while taking this drug.
This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.
Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical conditions and in combination with other drugs you are already taking.Do not start or stop taking any drug or change the dosage without your doctor’s approval.
What do I need to know or do while taking this drug?
For all purposes of this product:
- Tell all healthcare providers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
- With long-term use of the drug, a blood test should be performed.Talk to a medical professional.
- Avoid driving or other activities that require increased attention until you see how this drug affects you.
- If you have had seizures in the past, this drug may cause fainting. Use with care. Do not engage in activities that are unsafe in the event of fainting, such as driving or swimming.
- If you have lung disease, talk to your doctor.You may be more sensitive to the drug.
- Avoid drinking alcohol while taking this drug.
- Talk to your doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow you down.
- If this drug stops working for you, tell your doctor. Do not take the drug in higher doses than your doctor prescribed.
- If you have phenylketonuria, talk to your doctor.Some foods contain phenylalanine.
- If you are 65 years of age or older, use this drug with caution. You may have more side effects.
- When used during pregnancy, especially during the first trimester, the drug may have a harmful effect on the fetus.
- Taking this drug late in pregnancy may increase the risk of breathing or eating problems, low body temperature, or withdrawal symptoms in the newborn.Please consult your doctor.
- If you are pregnant or get pregnant while taking this drug, call your doctor right away.
Anti-seizure:
- Talk to your doctor if your seizures change or get worse after you start taking this drug.
- Do not change dosage or discontinue treatment. This can cause seizures. Talk to a medical professional.
What side effects should I report to my doctor immediately?
WARNING. In rare cases, some people with this drug can cause serious and sometimes deadly side effects. Call your healthcare professional or get medical attention right away if you have any of the following signs or symptoms, which may be associated with serious side effects:
- Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
- Shortness of breath.
- Balance change.
- Confusion of consciousness.
- Violation or loss of memory.
- Nightmares.
- Hallucinations (a person sees or hears something that is not in reality).
- Like other drugs used to treat seizures, this drug in rare cases may increase the risk of suicidal ideation or behavior. This risk may be higher in people who have attempted suicide or have had suicidal thoughts in the past.See your doctor right away if you develop or worsen symptoms such as depression, nervousness, anxiety, irritability, panic attacks, or other mood or behavior disorders. In case of suicidal thoughts or attempted suicide, contact your doctor immediately.
What are some other side effects of this drug?
Any medicine can have side effects. However, many people have little or no side effects.Call your doctor or get medical help if these or any other side effects bother you or do not go away:
- Feeling dizzy, sleepy, tired, or weak.
- Increased salivation.
- Signs of a cold.
This list of potential side effects is not comprehensive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.
You can report side effects to the National Health Office.
You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.
What is the best way to take this drug?
Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.
Tablets:
- Swallow whole with a full glass of water.
Lozenge:
- Do not touch the preparation with wet hands.
- Place the tablet on your tongue and let it dissolve. You do not need to drink water. Do not swallow the tablet whole. Do not chew, crush, or crush the tablet.
- If tablets are supplied in a foil blister, do not squeeze the tablet out of the foil when opening.The tablet should be removed from the foil with dry hands.
What to do if a dose of a drug is missed?
- Take the missed dose as soon as you can.
- If it is time for your next dose, do not take the missed dose and then return to your normal dose.
- Do not take 2 doses at the same time or an additional dose.
How do I store and / or discard this drug?
All forms of issue:
- Store at room temperature in a dry place.Do not store in the bathroom.
- Store this medication in a protected place, out of the reach of children, and out of the reach of other people. A box or room, which is locked with a key, can act as a protected storage location for the drug. Keep all medicines out of the reach of pets.
- Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so.If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.
Lozenge:
- Protect from light.
- If this medicine is packaged in a foil bag, store it in this container until use.
- Use orally disintegrating tablets immediately after opening the pack. Throw away all unused portions from the opened bag.
General information about medicines
- If your health does not improve or even worsens, see your doctor.
- Do not give your medicine to anyone or take other people’s medicines.
- Some medicines may come with other patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
- A separate patient instruction sheet is included with the product. Please read this information carefully. Reread it every time you replenish your supply. If you have questions about this drug, talk with your doctor, pharmacist, or other healthcare professional.
- If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.
Use of information by the consumer and limitation of liability
This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.
Copyright
© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.
Arpimed
Possible side effects
Like all medicines, clonazepam can cause side effects, although not everybody gets them.
Important side effects :
Allergic reactions .
If you develop an allergic reaction, see your doctor immediately.
Allergic reactions can manifest as the following symptoms:
- Sudden edema of the larynx, face, lips and mouth. These symptoms can lead to difficulty breathing or swallowing.
- Sudden swelling of the hands, feet and ankles.
- Skin rash or itching.
Adverse reactions from the cardiovascular system
If you develop any of these symptoms, you should see your doctor immediately.
These symptoms include:
- Shortness of breath, ankle swelling, cough, fatigue and heart palpitations.
- Pain in the chest area, which can radiate to the neck, shoulder and left arm.
Adverse reactions from the nervous system
If you develop any of these symptoms, you should talk to your doctor.
These symptoms include:
- Feelings of aggression, excitement, irritability, nervousness, agitation, anxiety and hostility.
- Sleep disturbance, nightmares and vivid dreams.
- Hallucinations, mania and speech impairment.
- Development of new types of seizures that were not previously observed
Children and babies
- Special supervision should be observed when taking clonazepam in children and infants, as clonazepam can lead to the development of impaired airway function, coughing and a feeling of suffocation.It can be caused by excessive salivation.
- Early puberty possible. After the cancellation of clonazepam, this process stops.
Other possible side effects
Taking clonazepam can lead to the following symptoms:
- Sleepiness and fatigue
- Dizziness and fatigue.
- Muscle weakness or flexibility, jerking movements (poor coordination of movements)
- Instability when walking
If you have any of these symptoms, tell your doctor.Your doctor will prescribe a low dose if necessary, gradually increasing your clonazepam dose.
The following symptoms may appear at any time clonazepam treatment
Mental activity and nervous system
- Impaired concentration, confusion and feelings of loss (disorientation)
- Feeling anxious
- Difficulty remembering new things
- Headache
- Depression
- Slow or choppy speech
- Poor coordination of movements, including unsteadiness when walking
- Increase in the incidence of epileptic seizures
Circulatory, renal and hepatic system
- Liver dysfunction (diagnosed by laboratory liver tests)
- Uncontrolled urination
- Problems with the circulatory system.Symptoms include feeling tired, bruising from minor concussions, shortness of breath, and nosebleeds.
Your healthcare professional should perform periodic blood tests as needed.
Gastrointestinal tract
- Nausea
- Stomach disorders
Visual organs
- Diplopia (double vision)
- Involuntary oscillatory movements (nystagmus)
Respiratory system
- Respiratory failure (respiratory depression).The first signs include sudden noisy, labored, and irregular breathing. The development of cyanosis of the skin is possible.
Skin and hair
- Skin rash, urticaria and pruritus.
- Skin discoloration
- Hair loss
Genital system
- Decreased libido
- Erectile dysfunction
Withdrawal syndrome
When benzodiazepines such as clonazepam are taken, drug dependence may develop.Therefore, with a sudden discontinuation or dose reduction of clonazepam, withdrawal syndrome may develop. Withdrawal can lead to the following symptoms:
- Sleep disorders
- Muscle pains, tremors and anxiety
- Feelings of increased anxiety, tension, irritability or anxiety, or mood changes
- Increased sweating
- Headache
Less common symptoms are:
- Increased sensitivity to light, noise and physical contact
- Hallucinations
- Tingling and numbness of hands and feet
- Feeling out of touch with reality
Injury
Patients taking benzodiazepines are at an excessive risk of falling or breaking bones, especially the elderly, patients taking sedatives, including alcohol.
Reporting side effects
If you notice any side effects, tell your doctor, pharmacist or pharmacist about it, including any side effects not listed in this leaflet. You can also report side effects to Arpimed LLC by going to the website www.arpimed.com and filling out the appropriate form “Report side effects or drug ineffectiveness” and to the Scientific Center for the Expertise of Drugs and Medical Technologies named afterAcademician E. Gabrielyan by going to the website www.pharm.am in the section “Report side effects of the drug” and fill out the form “Card of messages about side effects of the drug”. Scientific center hotline: +37410237665; +37498773368 By reporting side effects you are helping to gather more information on the safety of this medicine.
How to store Clonazepam
- The drug should be stored out of the reach of children, dry, protected from light at a temperature not exceeding 25 90 126 0 90 127 90 141
- Shelf life – 3 years.Do not take clonazepam after the expiration date printed on the drug package. The expiry date refers to the last day of the specified month.
- Do not throw away leftover tablets. Ask your doctor or pharmacist how to dispose of a drug you no longer need. Keep the medicine with you if your doctor has instructed you to do so.
- If the tablets are discolored or show other signs of deterioration, ask your pharmacist how to dispose of the drug.
Contents of the box and additional information
What Clonazepam contains
One tablet contains:
active substance – clonazepam – 2 mg;
excipients: microcrystalline cellulose, monohydrate lactose, corn starch, povidone, sodium starch glycolate, magnesium stearate, purified talc.
What Clonazepam looks like and contents of the pack:
White round flat tablets scored on one side.
Cardboard package containing 24 tablets (1 blister of 24 tablets) together with an enclosed leaflet.
Vacation conditions
Prescription
Rivotril | Health News | Search and ordering of medicines in pharmacies in St. Petersburg and the Leningrad region.
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03/23/2020
Find a drug in pharmacies
Trade name of the drug: Rivotril
International non-proprietary name: Clonazepam
Dosage form: tablets; intravenous solution
Active ingredient: Clonazepam
Pharmacotherapeutic group: Anticonvulsant
Pharmacological properties:
Antiepileptic drug from the group of benzodiazepine derivatives.It has a pronounced anticonvulsant, as well as central muscle relaxant, anxiolytic, sedative and hypnotic effects.
Strengthens the inhibitory effect of GABA on the transmission of nerve impulses. Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brain stem and interneurons of the lateral horns of the spinal cord. Reduces the excitability of the subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits postsynaptic spinal reflexes.
Anxiolytic action is due to the influence on the amygdala complex of the limbic system and is manifested in a decrease in emotional stress, relaxation of anxiety, fear, anxiety.
Sedation is due to the influence on the reticular formation of the brain stem and nonspecific nuclei of the thalamus and is manifested by a decrease in neurotic symptoms (anxiety, fear).
Anticonvulsant action is realized by strengthening presynaptic inhibition.In this case, the spread of epileptogenic activity that occurs in epileptogenic foci in the cortex, thalamus and limbic structures is suppressed, but the excited state of the focus is not removed.
It has been shown that clonazepam in humans rapidly suppresses paroxysmal activity of various types, incl. “spike-wave” complexes with absences (petit mal), slow and generalized “spike-wave” complexes, “adhesions” of temporal and other localization, as well as irregular “adhesions” and waves.
Generalized EEG changes are suppressed to a greater extent than focal.In accordance with these data, clonazepam has a beneficial effect in generalized and focal forms of epilepsy.
The central muscle relaxant effect is due to inhibition of polysynaptic spinal afferent inhibitory pathways (to a lesser extent and monosynaptic). Direct inhibition of motor nerves and muscle function is also possible.
Pharmacokinetics
The oral bioavailability is more than 90%. Plasma protein binding – more than 80%.Vd – 3.2 l / kg. T1 / 2 – 23 hours. It is excreted mainly in the form of metabolites.
Indications for use:
Epilepsy in infants and young children, especially typical and atypical absences (Lennox syndrome), nodding seizures, primary and secondary generalized tonic-clonic seizures. All forms of status epilepticus (IV and IM administration). Epilepsy in adults, focal seizures.
Contraindications:
Do not administer to newborns and premature babies.
Interaction with other medicinal products:
Alcohol reduces the effect. Barbiturates, hydantoins can accelerate the metabolism of clonazepam without affecting its protein binding.
Method of administration and dosage:
The dose is set individually. For oral administration, the initial dose for infants and children under 10 years of age (body weight up to 30 kg) is 0.01–0.03 mg / kg of body weight per day, the maintenance dose is 0.05–0.1 mg / kg / daysFor children over 10 years old and adults, the initial dose is 1-2 mg per day, the maintenance dose for children 10-16 years old is 1.5-3 mg, for adults – 2-4 mg / day. The maximum daily dose for adults is 20 mg. In the treatment of status epilepticus, children are injected 1/2 ampoule (0.5 mg) intravenously, slowly, in adults – 1 mg intravenously, slowly. If necessary, the introduction is repeated, possibly by intravenous infusion. The maximum daily dose for intravenous administration is about 13 mg. The drug is withdrawn gradually.
Special instructions:
In order to avoid an increase in the frequency of epileptic seizures, the transfer of patients to otherantiepileptic drugs are carried out gradually.
The addition of a new anticonvulsant drug to the treatment regimen requires a careful assessment of the effect of therapy, since the likelihood of adverse events such as sedation and apathy increases. In such cases, the dose of each drug must be adjusted to achieve the optimal desired effect.
During treatment with the drug, patients are strictly prohibited from using ethanol, since it can disrupt the effect of the drug, reduce the effectiveness of treatment or cause unforeseen side effects.
With long-term treatment, it is necessary to control the picture of peripheral blood and the activity of “liver” enzymes.
The risk of drug dependence formation increases with the use of large doses, a significant duration of treatment, in patients who have previously abused ethanol or drugs. In the case of drug dependence, abrupt withdrawal is accompanied by a withdrawal syndrome (headache, myalgia, anxiety, tension, confusion, irritability; in severe cases – derealization, depersonalization, hyperacusis, paresthesias in the extremities, light and tactile hypersensitivity; hallucinations and epileptic seizures ).
Respiratory depression may develop, especially with intravenous clonazepam. This effect is more likely if the patient previously had airway obstruction or brain damage, as well as with the appointment of other drugs that depress respiration. As a rule, this can be avoided with careful individual dose selection.
When in / in the introduction, it is necessary to select a vein of sufficient caliber and carry out the introduction very slowly, constantly monitoring breathing and blood pressure. If the injection is done quickly or if the vein is not of sufficient caliber, there is a risk of developing thrombophlebitis, which in turn can lead to thrombosis.
With prolonged use of Rivotril in children, one should bear in mind the possibility of side effects on physical and mental development, which may not appear for many years.
In pregnancy, it is prescribed after a careful assessment of the ratio between the expected therapeutic effect in the mother and the possible negative effect on the fetus. Cancellation of clonazepam before or during pregnancy is possible only if epileptic seizures are weak and infrequent in the absence of drug administration and the likelihood of epilepsy and withdrawal syndrome is low.When administered in the first trimester, the risk of congenital malformations increases. The appointment of large doses in the third trimester of pregnancy or during childbirth can lead to irregular heartbeat of the fetus, as well as hypothermia, arterial hypotension, mild respiratory depression and impaired sucking in the newborn. It should be remembered that both the pregnancy itself and the abrupt withdrawal of the drug can lead to an exacerbation of the course of epilepsy.
Continuous use during pregnancy can lead to physical dependence with the development of withdrawal syndrome in the newborn.
Use just before or during labor may cause muscle weakness in newborns.
During the period of drug treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Side Effects:
Fatigue, drowsiness, ataxia, changes in behavior (paradoxical agitation, irritation, aggressiveness), rarely – respiratory depression, urinary incontinence, muscle hypotension, visual disturbances and coordination; hypersalivation and bronchial hypersecretion in children.
Overdose:
Symptoms: drowsiness, confusion, paradoxical agitation, decreased reflexes, dysarthria, ataxia, nystagmus, tremor, bradycardia, shortness of breath or shortness of breath, severe weakness, decreased blood pressure, depression of cardiac and respiratory activity, coma.
Treatment: gastric lavage, intake of activated carbon. Symptomatic therapy (maintaining breathing and blood pressure). Hemodialysis is ineffective.
The benzodiazepine antagonist flumazenil is not indicated for patients with epilepsy who were treated with benzodiazepines.In such patients, the benzodiazepine antagonistic effect can provoke epileptic seizures.
Storage conditions:
In the dark place.
Keep out of reach of children.
Expiry date: 5 years.
Terms of dispensing from pharmacies: Prescription.
Manufacturer: Hoffmann-La Roche Ltd. (Switzerland)
Yandex recommends:
90,000 Rivotril.Tablets, oral, Reference of medicines. Tomsk
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Packing
Oral tablets
Pharmacological action
Antiepileptic drug from the group of benzodiazepine derivatives. It has a pronounced anticonvulsant, as well as central muscle relaxant, anxiolytic, sedative and hypnotic effects.
Strengthens the inhibitory effect of GABA on the transmission of nerve impulses. Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brain stem and interneurons of the lateral horns of the spinal cord.Reduces the excitability of the subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits postsynaptic spinal reflexes.
Anxiolytic action is due to the influence on the amygdala complex of the limbic system and is manifested in a decrease in emotional stress, weakening anxiety, fear, anxiety.
Sedation is due to the effect on the reticular formation of the brain stem and nonspecific nuclei of the thalamus and is manifested by a decrease in neurotic symptoms (anxiety, fear).The anticonvulsant action is realized by enhancing presynaptic inhibition. In this case, the spread of epileptogenic activity that occurs in epileptogenic foci in the cortex, thalamus and limbic structures is suppressed, but the excited state of the focus is not removed.
It has been shown that clonazepam in humans rapidly suppresses paroxysmal activity of various types, incl. complexes “spike-wave” with absences (petit mal), slow and generalized complexes “spike-wave”, “adhesions” of temporal and other localization, as well as irregular “adhesions” and waves.Generalized EEG changes are suppressed to a greater extent than focal ones. In accordance with these data, clonazepam has a beneficial effect in generalized and focal forms of epilepsy.
The central muscle relaxant effect is due to inhibition of polysynaptic spinal afferent inhibitory pathways (to a lesser extent and monosynaptic). Direct inhibition of motor nerves and muscle function is also possible.
Indications for use
Epilepsy in infants and young children, especially typical and atypical absences (Lennox syndrome), nodding seizures, primary and secondary generalized tonic-clonic seizures.All forms of status epilepticus (IV and IM administration). Epilepsy in adults, focal seizures.
Release form
tablets 0.5 mg; a bottle (bottle) of a dark slope 50, a pack of cardboard 1;
tablets 2 mg; a bottle (bottle) of a dark slope 30, a pack of cardboard 1;
tablets 2 mg; a bottle (bottle) of a dark slope 100, a pack of cardboard 1;
Pharmacodynamics
Interacts with specific benzodiazepine receptors located in the postsynaptic GABAA-receptor complex in the limbic system of the brain, the hypothalamus, ascending activating reticular formation of the brainstem and interneurons of the lateral horns of the spinal cord.Increases the sensitivity of GABA receptors to a mediator (GABA), which causes an increase in the frequency of opening channels in the cytoplasmic membrane of neurons for incoming currents of chlorine ions. As a result, there is an increase in the inhibitory effect of GABA and inhibition of interneuronal transmission in the corresponding parts of the central nervous system.
The clinical effect is manifested by a strong and long-term proto-dominal effect. It also has an antiphobic, sedative (especially pronounced at the beginning of treatment), muscle relaxant and moderate hypnotic effect.It is believed that the anticonvulsant effect of clonazepam is associated primarily with the effect on the GABAA-receptor complex, and also due to the effect on voltage-gated sodium channels.
Pharmacokinetics
Oral bioavailability is more than 90%. Plasma protein binding – more than 80%. Vd – 3.2 l / kg. T1 / 2 – 23 hours. It is excreted mainly in the form of metabolites.
Use during pregnancy
Use during pregnancy and childbirth is allowed only on strict indications, if the expected effect of therapy outweighs the potential risk to the fetus.In women taking clonazepam, its withdrawal before or during pregnancy is possible only in cases where, if untreated, epileptic seizures are mild and rare and if the likelihood of status epilepticus and withdrawal symptoms is assessed as low. There are reports that the use of anticonvulsants during pregnancy by women with epilepsy increases the incidence of birth defects in their babies.
FDA category of action on the fetus – D.
During treatment, breastfeeding should be discontinued.
Contraindications to use
Do not recognize newborn and premature babies.
Side effects
Fatigue, drowsiness, ataxia, changes in behavior (paradoxical agitation, irritation, aggressiveness), rarely – respiratory depression, urinary incontinence, muscle hypotension, visual disturbances and coordination; hypersalivation and bronchial hypersecretion in children.
Method of application and dosage
Individual. For oral administration, an initial dose of no more than 1 mg / day is recommended for adults.The maintenance dose is 4-8 mg / day.
For infants and children aged 1-5 years, the initial dose should be no more than 250 mcg / day. For children aged 5-12 years – 500 mcg / day. Maintenance daily doses for children under 1 year old – 0.5-1 mg, 1-5 years old – 1-3 mg, 5-12 years old – 3-6 mg.
For elderly patients, an initial dose of no more than 500 mcg is recommended.
The daily dose should be divided into 3-4 equal doses. Maintenance doses are prescribed after 2-3 weeks of treatment.
IV (slowly) adults – 1 mg, children under 12 years old – 500 mcg.
Overdose
Symptoms: depression of the central nervous system of varying severity (from drowsiness to coma): severe drowsiness, prolonged confusion, inhibition of reflexes, coma; respiratory depression is possible.
Treatment: induction of vomiting and administration of activated charcoal (if the patient is conscious), gastric lavage through a tube (if the patient is unconscious), symptomatic therapy, monitoring of vital functions (respiration, pulse, blood pressure), intravenous administration of fluids (to enhance urine output ), if necessary – mechanical ventilation.As a specific antidote, it is possible to use a benzodiazepine receptor antagonist flumazenil (in a hospital setting), however, flumazenil is not indicated for use in patients with epilepsy (a high probability of provoking epileptic seizures).
Interaction with other drugs
Alcohol reduces the effect. Barbiturates, hydantoins can accelerate the metabolism of clonazepam without affecting its protein binding.
With simultaneous use with drugs that have a depressing effect on the central nervous system, ethanol, ethanol-containing drugs, it is possible to increase the inhibitory effect on the central nervous system.With the simultaneous use of clonazepam enhances the effect of muscle relaxants; with sodium valproate – weakening the action of sodium valproate and provoking seizures.
With simultaneous use, a case is described of a decrease in the concentration of desipramine in blood plasma by 2 times and its increase after the withdrawal of clonazepam.
With simultaneous use with carbamazepine, which causes the induction of microsomal liver enzymes, an increase in metabolism is possible and, as a result, a decrease in the concentration of clonazepam in blood plasma, a decrease in its T1 / 2.With simultaneous use with caffeine, it is possible to reduce the sedative and anxiolytic effect of clonazepam; with lamotrigine – a decrease in the concentration of clonazepam in blood plasma is possible; with lithium carbonate – the development of neurotoxicity.
With simultaneous use with primidone, the concentration of primidone in plasma increases; with tiapride – the development of ZNS is possible.
With simultaneous use with toremifene, a significant decrease in AUC and T1 / 2 of toremifene is possible due to the induction of microsomal liver enzymes under the influence of clonazepam, which leads to an acceleration of the metabolism of toremifene.A case of development of headache localized in the occipital region with simultaneous use with phenelzine is described.
With simultaneous use, it is possible to increase the concentration of phenytoin in the blood plasma and the development of toxic reactions, a decrease in its concentration or the absence of these changes.
With simultaneous use with cimetidine, side effects from the central nervous system increase, however, the frequency of seizures in some patients decreased.
Special instructions when taking
Use with extreme caution in patients with ataxia, severe liver disease, severe chronic respiratory failure, especially in the stage of acute deterioration, with episodes of nocturnal apnea.It is used with caution in elderly patients, therefore, their elimination of clonazepam may be slowed down and tolerance may be reduced, especially in the presence of cardiopulmonary insufficiency.
With prolonged use, drug dependence may develop. With a sharp withdrawal of clonazepam after long-term treatment, withdrawal syndrome may develop.
With long-term use of clonazepam in children, one should bear in mind the possibility of side effects on physical and mental development, which may not appear for many years.Avoid drinking alcohol during treatment.
Influence on the ability to drive vehicles and control mechanisms
During the period of treatment, a slowdown in the speed of psychomotor reactions is observed. This must be taken into account by persons engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Storage conditions
In the dark place.
Expiry date
60 months
instructions, use, analogues of the drug, composition, indications, contraindications, side effects in the reference book of medicines from UNIAN
Clonazepam use
Clonazepam – composition and release form of the drug
Clonazepam: how to take the drug
Clonazepam – contraindications, side effects
Clonazepam belongs to the group of benzodiazepine derivatives.The clinical effect of the drug is manifested by a strong and prolonged anticonvulsant effect; acts anxiolytic, sedative, sedative, moderately hypnotic, and also moderately muscle relaxant.
Application of Clonazepam
Indications for use:
- Epilepsy in infants, preschool and school children (mainly typical and atypical seizures of minor epilepsy and primary or secondary generalized tonic-clonic crises).
- Epilepsy in adults (mainly focal seizures).
- Paroxysmal fear syndrome, a state of fear with phobias, for example, with agoraphobia (do not use in children).
- State of psychomotor agitation against the background of reactive psychoses.
Clonazepam – composition and release form of the drug
The drug is available in the form of tablets of pale orange (dosage 0.5 mg), pale purple (dosage 1 mg), white (dosage 2 mg) color.
1 tablet contains clonazepam 0.5 mg, or 1 mg, or 2 mg;
Excipients: lactose monohydrate, potato starch, calcium stearate, gelatin, dyes (sunset yellow FCF (E 110) – for a dosage of 0.5 mg; purple [ponso 4R (E 124), indigo carmine (E 132)] – for a dosage of 1 mg).
Clonazepam: how to take the drug
The drug should be taken orally without chewing and drinking a small amount of liquid. The dose and duration of therapy is determined by the doctor individually for each patient, taking into account the nature, severity and characteristics of the course of the disease, the stability of the achieved therapeutic effect and the tolerability of the drug. Treatment should be started with low doses, increasing gradually until a therapeutic effect is obtained.
For epilepsy
Adults. The starting dose is 1 mg / day and is divided into 3 doses. The dose should be gradually increased by 0.5-1 mg every 3 days until the optimal effect is obtained.
The maintenance dose is set individually for each patient, depending on the therapeutic effect (usually 4-8 mg / day in 3-4 doses) and is achieved within 2-4 weeks.
The maximum daily dose is 20 mg.
Elderly patients are especially sensitive to the effects of central depressants, and therefore it is recommended to start therapy with a daily dose not exceeding 0.5 mg.A maintenance dose should be achieved after 2-4 weeks of treatment.
Children. The starting dose for infants and children 1 to 5 years of age is 0.25 mg / day. For children over 6 years of age, the initial dose is 0.5 mg / day. The dose can be gradually increased by 0.5 mg every 3 days until a satisfactory therapeutic effect is obtained.
Maintenance daily dose:
– for infants under 1 year old – 0.5-1 mg,
– for children aged 1 to 5 years – 1-3 mg,
– for children aged from 6 to 12 years old – 3-6 mg.
The maximum daily dose for children is 0.2 mg / kg body weight.
Temporary withdrawal: in some forms of childhood epilepsy, some patients may experience a decrease in the therapeutic effect of clonazepam. An adequate therapeutic effect can be restored by increasing the dose of the drug or temporarily discontinuing clonazepam therapy for a period of 2 to 3 weeks. During this time, careful monitoring of the patient’s condition is necessary, in particular, alternative drug therapy may be advisable.
For children under 3 years of age, grind the required number of tablets to a powdery state, dissolve in a small amount of water and apply as a suspension.
With paroxysmal fear syndrome
For adults the initial dose is 0.5 mg / day, the dose is divided into 2 doses. The average dose is 1 mg / day. To reduce sleepiness during the day, the drug can be taken once in a daily dose at bedtime. The maximum daily dose is 4 mg.
The safety and efficacy of clonazepam in children with paroxysmal fear syndrome have not been established.
Children.
The drug can be used in pediatric practice. For children under 3 years old, grind the required number of tablets to a powdery state, dissolve in a small amount of water and apply as a suspension.
Do not prescribe to children for the treatment of paroxysmal fear syndrome, a state of fear in phobias (eg agoraphobia).
Clonazepam – contraindications, side effects
Contraindications.
- Hypersensitivity to benzodiazepines or any other components of the drug.
- Respiratory disorders of central origin and severe conditions of respiratory failure, whatever the cause;
- Sleep apnea syndrome, angle-closure glaucoma, impaired consciousness, myasthenia gravis, severe hepatic or renal failure, alcohol abuse, drug or drug addiction.
- Clonazepam should not be used during pregnancy unless absolutely necessary. Should not be used by mothers who are breastfeeding.
- Avoid driving or driving other machinery and other hazardous activities while using clonazepam, especially during the first few days of treatment.
Adverse reactions to Clonazepam
- Psychiatric disorders and paradoxical reactions: anterograde amnesia; it is possible to develop such paradoxical effects as aggressiveness, excitability, nervousness, hostility, anxiety, sleep disturbances, nightmares, vivid dreams, irritability, agitation, mental disorders and the appearance of new types of seizures.
- From the nervous system: dizziness, a feeling of emptiness or “lightness in the head”, drowsiness, increased fatigue, impaired coordination of movements, muscle hypotonia, muscle weakness, decreased concentration, memory impairment, impaired ability to absorb information, anxiety, headache pain, confusion, and disorientation; rarely – emotional lability, and the like.
- From the side of the organs of vision : diplopia and nystagmus are reversible disorders and occur especially with prolonged treatment or with the use of high doses.
- From the cardiovascular system : Heart failure has been reported, including cardiac arrest.
- From the side of systems blood and of the lymphatic system : isolated cases of pathological changes in the blood.
- On the side of the respiratory system , of the mediastinum and chest : intravenous use of clonazepam rarely causes respiratory depression, especially when other drugs have been used that have a depressing effect; in infants and young children, especially those with mental disorders, increased production of saliva or bronchial secretions from salivation may occur.
- Rarely, symptoms of catarrhal inflammation of the upper respiratory tract may occur.
- From the digestive tract: increased saliva secretion, decreased appetite, abdominal pain, constipation, nausea, vomiting, gastrointestinal symptoms.
- From the hepatobiliary system: isolated cases of abnormal values of liver function tests were reported.
- Skin and subcutaneous tissue disorders: rarely – urticaria, itching, temporary hair loss, changes in skin pigmentation.
- From the musculoskeletal system and connective tissue: muscle weakness, episodic muscle hypotension; rarely, muscle pain.
- From the genitourinary system: rarely – urinary incontinence; frequent urination, menstrual irregularities.
- In rare cases, erectile dysfunction and loss of libido may occur.
- From of the side of the endocrine system: isolated cases of reversible development of premature appearance of secondary sexual characteristics in children (incomplete early puberty) were reported.
- From side of the immune system: allergic reactions and several cases of anaphylaxis and angioedema.
- If physical dependence develops, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms.
- An increased risk of falls and fractures has been reported in elderly patients who use benzodiazepines.
- In rare cases, there may be a decrease in the number of platelets. As with other benzodiazepines, isolated cases of blood dyscrasia are possible.
Clonazepam analogs
Source: State Register of Medicines of Ukraine. The instructions are published with abbreviations for information only. Before use, consult your doctor and read the instructions carefully. Self-medication can be harmful to your health.
“Rivotril” or “Phenobarbital tablets”? – meds.is
Comparison of the effectiveness of Rivotril and Phenobarbital tablets
The effectiveness of Rivotril is quite similar to the Phenobarbital tablet – this means that the ability of the drug to have the maximum possible effect is similar.
For example, if the therapeutic effect of Rivotril is more pronounced, then when using Phenobarbital tablets, even in large doses, it will not be possible to achieve this effect.
Also, the rate of therapy is an indicator of the speed of therapeutic action in Rivotril and Phenobarbital tablets are approximately the same. And bioavailability, that is, the amount of a medicinal substance reaching the site of its action in the body, is similar. The higher the bioavailability, the less it will be lost when absorbed and used by the body.
Comparison of the safety of Rivotril and Phenobarbital tablets
The safety of the drug includes many factors.
At the same time, in Rivotril it is quite similar to the Phenobarbital tablet. It is important where the drug is metabolized: medicinal substances are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often it involves major organs such as the liver, kidneys, lungs, skin, brain, and others.When evaluating metabolism in Rivotril, as well as in Phenobarbital tablets, we look at which organ is metabolizing and how critical is the effect on it.
Risk-to-benefit ratio is when the prescription of a medicinal product is undesirable, but justified under certain conditions and circumstances, with mandatory caution in use. At the same time, Rivotril has no risks when used, as well as Phenobarbital tablets.
Also, when calculating safety, it is taken into account whether only allergic reactions are manifested or possible dysfunction of the main organs.In other matters, as well as the reversibility of the consequences of the use of Rivotril and Phenobarbital tablets.
Comparison of contraindications of Rivotril and Phenobarbital tablets
Based on the instructions. The number of contraindications for Rivotril is quite similar to the Phenobarbital tablet and is a small amount. This is a list of symptoms with syndromes, and diseases, various external and internal conditions under which the use of Rivotril and Phenobarbital tablets may be undesirable or unacceptable.
Comparison of addiction between Rivotril and Phenobarbital tablets
Like safety, addiction also includes many factors that must be considered when evaluating a drug.
So the set of values of such parameters as “withdrawal syndrome” and “development of resistance” in Rivotril is quite similar to those in Phenobarbital tablets. Withdrawal syndrome is a pathological condition that occurs after the termination of the intake of substances that cause addiction or dependence into the body.And by resistance is meant the initial resistance to the drug, in this it differs from addiction, when the resistance to the drug develops over a certain period of time. The presence of resistance can be ascertained only if an attempt was made to increase the dose of the drug to the maximum possible. At the same time, Rivotril’s values of “withdrawal syndrome” and “resistance” are quite small, however, just like in Phenobarbital tablets.
Comparison of the side effects of Rivotril and Phenobarbital tablets
Adverse events or adverse events are any medically adverse event occurring in a subject following administration of a drug.
In Rivotril, the state of adverse events is almost the same as in Phenobarbital tablets. They both have few side effects. This implies that the frequency of their manifestation is low, that is, the indicator of how many cases of manifestation of an undesirable effect from treatment is possible and registered is low. The undesirable effect on the body, the strength of the influence and the toxic effect of Rivotril is similar to the Phenobarbital tablet: how quickly does the body recover after taking it and whether to recover at all.
Comparison of the ease of use of Rivotril and Phenobarbital tablets
This is the selection of the dose, taking into account various conditions, and the frequency of receptions. At the same time, it is important not to forget about the form of release of the drug, it is also important to take it into account when drawing up an assessment.
The ease of use of Rivotril is better than that of Phenobarbital tablets.
The drug rating is compiled by experienced pharmacists studying international research.